AKI Risk Factors Analysis After Intentional Hypotensive Anesthesia

Recruiting

• Conditions: Acute Kidney Injury (Nontraumatic); Hypotension Drug-Induced

• Registration Number: NCT06259760
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

This project investigates intentionally hypotensive management such as NTG (nitroglycerin) or NTG+Trandate during general anesthesia in patients undergoing orthognathic surgery. Throughout the entire surgical procedure, blood biochemical and urine monitoring will be conducted. Serum creatinine (Cr) levels, urine analysis, and perioperative monitoring will be utilized as indicators for assessing renal function during the surgery. The objective is to assess its potential renal injury and identify early risk factors for acute kidney injury (AKI). Timely recognition of these factors will allow for the implementation of appropriate intervention strategies, aiding in the prevention of postoperative acute kidney injury. This approach contributes to achieving the goals of Enhanced Recovery After Surgery (ERAS) for surgical patients, promoting faster postoperative recovery.

Detailed Description

Orthognathic surgery is currently a common procedure in oral and maxillofacial surgery. The facial region is composed of a complex and dense vascular network, requiring precise, accurate, and delicate surgical techniques on both hard and soft tissues. During intraoral procedures, the surgical field may be limited, making the management of surgical bleeding challenging. Controlled hypotension or hypotensive anesthesia is often employed during major maxillofacial surgeries to optimize conditions. Lowering blood pressure is advantageous as it helps reduce overall blood loss and improves the surgeon's visibility. Therefore, maintaining stable blood pressure within the ideal range during the surgical process is a critical anesthesia objective.

This research emphasizes the prevention of acute kidney injury (AKI) in patients undergoing orthognathic surgery with intentional hypotension during general anesthesia. The goal is to detect the potential renal damage at an early stages, before a significant decline in kidney function occurs, thereby reducing the likelihood of acute kidney injury.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Last Update Submitted: 2024-02-07
• Study First Posted: 2024-02-14
• Last Update Posted: 2024-02-14
• Study Start: 2024-03-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• America society anesthesiologist classification class I to II patients undergoing oro-maxillo-facial surgery
• unlimited mouth opening

Exclusion Criteria

• patients with arthritis with limited mouth opening
• persistent liver dysfunction
• chronic renal insufficiency
• body mass index ≧35 kg/m2.
• past history of malignant hyperthermia or personal or family history
• diabetes with insulin treatment
• essential hypertension without controlled

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
consumption of inhaled and intravenous anesthetics	intraoperative 2-6 hours	to maintain adequate depth of anesthesia during intentional hypotension, consumptions of inhaled and intravenous anesthetics are calculated
urine biomarkers assessment, urine output, and blood Creatinine from participants undergoing Orthognathic surgery.	intraoperative and postoperative stages, assessed up to 24 hours	Record blood and urine biomarkers, and urine output after operation
permitted hypotension during surgery	intraoperative 2-6 hours	assess intraoperative blood loss and the dosage of hypotensive medications to decrease intra-operative bleeding as patient undergoing oromaxillofacial surgery, intentional hypotension is allowed. however, adequate depth of anesthesia, proper cardiac output, respiratory parameters, temperatures should be monitored

Secondary Outcome Measures

Name	Time	Method
safely discharged from post-anesthesia care unit (postoperative recovery room)	2 hours	as calculating the time from patient is delivered to postoperative recovery room to be safely discharged from recovery room by using the aldrete scores (activities level, respiration, circulation, conscious level, oxygenation) full back to pre-operative level or ten scores.
side effects and adverse events	intraoperative and postoperative stages, assessed up to 48 hours	records any abnormal surgical or anesthesia related findings during this admission
time to successfully extubate the nasotracheal tube after anesthesia	from the end of surgery to the post-anesthesia care, assessed up to one hour	early extubation allowable

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Sanmin Dist, Taiwan